An interventional study of Modeling Resin Insertion Technique and Conventional resin composite Incremental Placement Technique in Class I Composite Restorations, sponsored by Cairo University. Status unknown. Open to participants aged 25 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-06.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
Evaluation of Resin Composite Posterior Restorations Using Modeling Resin Insertion Technique versus Conventional Composite Placement Technique in Class I Lesions: Randomized Clinical Trial
Statement of the problem In a restorative procedure, an important objective is to obtain restorations with smooth surfaces. Surface roughness has a major influence on plaque accumulation, secondary caries, and gingival irritation. Further, it may directly influence wear behavior and the marginal integrity of composite restorations. A roughened surface of a resin composite restoration is also likely to be stained by exogenous sources, such as coffee, tea, or red wine, leading to the discoloration of the material.
One of the main drawbacks of sculpting composite restorations is that some materials are sticky, reducing the ease of handling and insertion of the material into the tooth cavity. Some materials readily adhere to the composite instruments; thus, limiting reestablishment of the shape and anatomical contour of the tooth. As a result, the application of lubricants on the composite instrument such as modeling liquids/resins between the layers of composite have been proposed.
Rationale Modeling resins can be directly applied between the layers using a brush or can be used as a lubricant on manual instruments. In both the aforementioned techniques, the ease of instrumentation during the placement of esthetic restorations is superior, compared to the traditional restorative techniques. Moreover, any pores or gaps on the surface of the composite placed by means of the layering technique can be easily resolved. Hence, the modeling resin facilitates the reduction of defects in the body of the restoration and aids in improving the mechanical properties.
Although these methods are widely used, a potential shortcoming is that these techniques may adversely affect the physical and surface properties of the resin composite. However, it is unknown whether different compositions of adhesives or modeling agents may affect the surface microhardness, surface roughness, and color stability of composites over time.
Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants:
Teeth:
Exclusion Criteria:
Participants:
Teeth:
Resin Composite (Tetric® N-Ceram Nano-hybrid incremental composite) / Wetting Agent (Modeling Resin, Bisco)
Procedure: Modeling Resin Insertion Technique
Conventional resin composite incremental placement technique (Tetric® N-Ceram Nano-hybrid incremental composite)
Procedure: Conventional resin composite Incremental Placement Technique
One drop of modeling resin will be dispensed into a clean mixing well. Following the placement of the resin composite into the prepared site, a composite instrument (round-ended plugger with a diameter of 2 mm) will be dipped into the modeling resin. With modeling resin on the instrument, the resin composite is sculpted and manipulated to the desired shape. This will be repeated with each increment. Each increment will be polymerized for 20 sec with a LED light-curing unit.
A three-step etch-and-rinse adhesive system will be used according to the manufacturer's instructions. 37.5% phosphoric acid (Kerr Co, Orange, CA, USA) will be applied to the enamel and dentin for a period of 30 s and 15 s, respectively. Subsequently the cavities will then be rinsed with an air/water spray for 15 s. A layer of primer will be applied to the dentin for 30 sec, afterward gentle air-drying for 5 sec. Then, the bond (AdheSE adhesive) will be applied on the enamel and dentin and light cured with a LED curing unit for about 30 sec. Tetric N-Ceram will then be applied using an incremental filling technique, each increment will not exceed 2mm in thickness. Each increment will be polymerized for 20 sec with a LED light-curing unit.
Change from baseline in Marginal Discoloration at 3,6,12 & 18 months
Modified US Public Health Service criteria. Possible scores range from alpha (Excellent) to delta (Immediate replacement necessary).
Time frame: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Change from baseline in Marginal Integrity at 3,6,12 & 18 months
Modified US Public Health Service criteria. Possible scores range from alpha (Excellent) to delta (Immediate replacement necessary).
Time frame: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Change from baseline in Color Match at 3,6,12 & 18 months
Modified US Public Health Service criteria. Possible scores range from alpha (Excellent) to charlie (outside the acceptable range).
Time frame: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Change from baseline in Surface Roughness at 3,6,12 & 18 months
Modified US Public Health Service criteria. Possible scores range from alpha (Excellent) to delta (Immediate replacement necessary).
Time frame: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Change from baseline in Anatomic form (wear) at 3,6,12 & 18 months
Modified US Public Health Service criteria. Possible scores range from alpha (Excellent) to delta (Immediate replacement necessary).
Time frame: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Change from baseline in Retention of Restoration at 3,6,12 & 18 months
Modified US Public Health Service criteria. Possible scores range from alpha (Excellent) to charlie (complete loss of restoration).
Time frame: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Change from baseline in Secondary Caries at 3,6,12 & 18 months
Modified US Public Health Service criteria. Possible scores range from alpha (Excellent) to bravo (Caries contiguous with the restoration margin).
Time frame: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Change from baseline in Postoperative Sensitivity at 3,6,12 & 18 months
Modified US Public Health Service criteria. Possible scores range from alpha (Excellent) to delta (Immediate replacement necessary).
Time frame: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
No study locations are listed for this record.
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Cairo University